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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, hypodermic, single lumen
510(k) Number K121632
Device Name COMFORT EZ
Original Applicant
8870 ravello ct
naples,  FL  34114
Original Contact daniel kamm
Regulation Number880.5570
Classification Product Code
Date Received06/04/2012
Decision Date 08/10/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No